GE Salmon,coming soon?

Nearly 400,000 people sent letters to the FDA during their comment period in October,asking for mandatory labeling of AquaBounty’s GE salmon,at the very least. You can visit the Center for Food Safety for more information and quick links to action steps. This is precedent-setting time for how we as a country handle GE animals

This is excerpted from an article by Jill Richardson which appeared in Grist Magazine on September 20th 2010

“We’re about to enter a brave new world in which transgenic,or genetically engineered (GE,as they are more commonly known),food animals may soon be appearing on our plates. An FDA special committee is meeting right now to determine whether a GE fish —AquAdvantage salmon,genetically engineered by AquaBounty Technologies to reach mature size more quickly,thanks to genes from the Chinook salmon and from the eel-like ocean pout —is safe for human consumption. The approval process for the GE salmon will set a precedent for all future GE animals;if the FDA does not set the bar high for solid science,it will mean a lack of scrutiny for other,perhaps less safe,GE animals in the future.

Unfortunately,the FDA appears poised to rubber-stamp the AquAdvantage salmon. After working with AquaBounty since the mid-1990s on the application for the GE salmon,the FDA has only just recently released 255 pages of technical information —and then allowed a mere 14 days for the public to comment on it. And there is something decidedly fishy about the makeup of the committee chosen to weigh the scientific risk assessments. One might say that the scales are heavily weighted in favor of pro-biotech interests.

The FDA is regulating the GE salmon as a “New Animal Drug,”in agency terminology,and it is thus being evaluated by a special Veterinary Medicine Advisory Committee (VMAC) meeting today and yesterday. Consumers Union,the nonprofit watchdog group and publisher of Consumer Reports,has written a letter to the FDA and formally submitted comments protesting aspects of this approval process,from the shortened time frame,committee makeup,and data rigor (or lack of it). In the latest twist, the GE salmon data was taken from a small sample of fish raised in a facility in Prince Edward Island,whereas AquaBounty actually plans to raise the fish in Panama;thus,approving the fish based on the current data actually represents a violation of the law.

…Consumers Union in its letter recommends adding “three fish ecologists,four food safety experts (including specialists in food allergies and in the effects of hormones on human health),and scientists from the consumer and environmental community …to the Committee,to provide appropriate balance and expertise.”

Ana-filet-actic shock

Consumers Union also has many concerns about the safety of the fish,specifically increased allergenicity:

Because FDA’s assessment is inadequate,we are particularly concerned that this salmon may pose an increased risk of [severe],even life-threatening allergic reactions to sensitive individuals.  Instead of approving this product,FDA should be requiring studies with data from many more engineered fish,not the tiny sample of six fish [emphasis added] on which it currently bases its conclusions.

Consumers Union is also concerned about the lack of data on fish raised at the Panama facility where the GE salmon,if approved,will be raised. The data used in the FDA assessment of the GE salmon’s safety was all taken from fish raised at a facility in Prince Edward Island. The FDA itself acknowledges that “the culture (e.g.,water temperature,pH,alkalinity,etc.) were likely to be significantly different from the facility at PEI as a result of differences in,among others,water surface,facility design,and environmental factors due to geographic location. . . .  the effect of the difference between the PEI and Panama facilities,especially temperature,on the resulting AquAdvantage phenotype is unknown.”

Consumers Union notes that this is a legal violation,based on the law the FDA is using to regulate the GE salmon:

FDA is regulating the GE salmon as a New Animal Drug,with the NAD being the genetic (e.g. rDNA) construct itself. Thus,the husbandry and rearing conditions of GE fish into which the genetic construct has been inserted would constitute the production process. Under the NAD provisions of the Federal Food Drug and Cosmetics Act (FFDCA),a NAD is granted for a specific production process;if a company changes the production process for a NAD,the company must submit data to the FDA to show that such a change does not have an effect on the safety or efficacy of the NAD,i.e. the FDA does not assume that drugs made with different production processes are equivalent and requires data to show they are equivalent.  Since the husbandry/rearing conditions differ between Panama and PEI —the former being in the tropics,the latter in the temperate zone —this means that the production process (e.g. husbandry/rearing conditions) differs as well,and FDA should require Aqua Bounty to submit data showing that it does not impact the safety of the NAD. FDA should insist,for example,that the rearing conditions in Panama do not increase the levels or potency of allergenic proteins in the salmon.

Requiring new data would,of course,slow down what has all of a sudden become a mad rush to approve an entirely new product.

Why is the FDA accepting such sloppy science,flouting its own regulations,giving the public nearly no time to weigh in,and packing its committee full of biotech hacks who will not ask the tough questions necessary to ensure the AquAdvantage salmon is safe before it winds up (unlabeled,the Washington Post reports) on our plates?”